Epix Plans To Appeal FDA Drug Decision

Law360, New York (December 15, 2006, 12:00 AM EST) -- EPIX Pharmaceuticals Inc. said Friday that it plans to appeal a decision by the U.S. Food and Drug Administration denying approval of blood-pool imaging agent Vasovist.

The FDA’s Office of New Drugs denied the company’s previously submitted appeal, so it will now appeal to the director of the Center for Drug Evaluation and Research at the agency.

EPIX said it would submit the appeal at the beginning of 2007.

The company said it is appealing because it “vigorously disagrees” with the prior determinations that Vasovist has...
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